Integra Neurosciences

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
7
Compliance Actions
2

Recent 510(k) Clearances

K-NumberDeviceDate
K082250AURAGEN CORTICAL SURFACE ELECTRODESOctober 10, 2008
K050720NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100May 11, 2005
K042277SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEMSeptember 29, 2004
K031086CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1May 14, 2003
K021989SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3September 13, 2002
K022554MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEMAugust 23, 2002
K022553CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4LAugust 20, 2002
K020558LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBEMarch 21, 2002
K002765LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3November 24, 2000